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eRT Remote Health Monitoring

This study is currently recruiting participants.
Verified July 2012 by University of California, Los Angeles
Sponsor:
Collaborator:
eResearch Technology (eRT)
Information provided by (Responsible Party):
Christopher B Cooper, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01495780
First received: December 16, 2011
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).

Subjects will complete 2 visits at UCLA, separated by one year of RHM or regular COPD care. Subjects will be randomized on a 2:1 basis to participate in RHM or not. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
COPD
Chronic Obstructive Lung Disease
Bronchitis, Chronic
Pulmonary Emphysema
 Behavioral: Remote Health Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Compliance with daily RHM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compliance with daily RHM as a percentage of study days

  • Integrity of spirometric data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.


Secondary Outcome Measures:
  • Rate of adoption of RHM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time it takes for subjects to become compliant with daily RHM

  • Treatment adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)

  • Time to first COPD exacerbation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time to first COPD exacerbation as defined by standard criteria.

  • Number of COPD exacerbations per year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing one or more exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean daily FEV1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean daily IC [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean daily activity level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean daily SpO2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Daily symptom scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of physician visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of emergency department visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of hospitalizations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of days spent in hospital [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health care costs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Inferred health care costs using a standard cost framework model


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
Subjects assigned to the standard of care arm will continue their usual COPD care without any changes due to study participation.
Experimental: Remote Health Monitoring
Subjects assigned to this arm will conduct daily at-home health monitoring using several electronic devices that will transmit data back to the study team. Everyday, subjects will measure pulse oximetry (SpO2) using a finger clip, answer questions about symptoms and medication use, answer a quality of life questionnaire, perform breathing tests, and record physical activity (using a physical activity monitor that will be mailed to the study team).
 Behavioral: Remote Health Monitoring
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >40 years.
  • Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9
  • Smoking history >10 pack-years.
  • Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values
  • Domestic situation felt to be supportive of remote health monitoring.
  • Ability to give informed consent.

Exclusion Criteria:

  • Clinical diagnosis of asthma.
  • Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.
  • Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).
  • Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.
  • Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.
  • Myocardial infarction within 6 weeks of enrolment.
  • Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.
  • A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495780

Contacts
Contact: Milan Patel, B.S. 310-825-2517 mhpatel@mednet.ucla.edu
Contact: John Wheeler, M.A. 310-825-2616 jwheeler@mednet.ucla.edu

Locations
United States, California
UCLA David Geffen School of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Milan Patel, B.S.     310-825-2517     mhpatel@mednet.ucla.edu    
Contact: John Wheeler, M.A.     310-825-2616     jwheeler@mednet.ucla.edu    
Principal Investigator: Christopher B Cooper, M.D.            
Principal Investigator: Thomas Storer, Ph.D.            
Sub-Investigator: Brett Dolezal, Ph.D.            
Sub-Investigator: Eric Kleerup, M.D.            
Sub-Investigator: Michelle Zeidler, M.D.            
Sub-Investigator: Tisha Wang, M.D.            
Sub-Investigator: Patricia Eshaghian, M.D.            
Sub-Investigator: Irawan Susanto, M.D.            
Sponsors and Collaborators
University of California, Los Angeles
eResearch Technology (eRT)
Investigators
Principal Investigator: Christopher B Cooper, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Christopher B Cooper, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01495780     History of Changes
Other Study ID Numbers: eRT RHM
Study First Received: December 16, 2011
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Behavioral
Remote monitoring

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Chronic Disease
Emphysema
Pulmonary Emphysema
Lung Diseases
 Respiration Disorders
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013